The following guidance which has been developed in preparation for the implementation of the Clinical Trial Regulation (EU) No 536/2014 is currently out for public consultation from 1 June 2016 to 31 August 2016 by the European Commission:

Risk Proportionate Approaches in Clinical Trials
The main objective of this document is to provide further information on how a risk proportionate approach can be implemented in clinical trials and highlights areas within the clinical trials Regulation which support such adaptations.

Summary of Clinical Trial Results for Laypersons
Article 37 of the Clinical trial Regulation (EU) No 536/2014 requires that sponsors provide a summary of clinical trial results in the EU Portal and Database, in a format understandable to laypersons. The main objective of this document is to provide recommendations and templates for the production of a summary of clinical trial results for laypersons by sponsors and investigators, in accordance with Annex V of the EU Clinical Trials Regulation.

Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs)" (previously called "Guidance on Investigational Medicinal Products (IMPS) and Non-Investigational Medicinal Products (NIMPs))
The main objective of this revision is to align it with the Clinical Trials Regulation and with the latest (scientific) insights.

Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors
The main objective of this revision is to align the document with the Clinical Trials Regulation (EU) No 536/2014 and with the latest (scientific) insights on research with children.